Z-0033-2018Class II

Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and...

Name: Z-0033-2018 Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and...
Creator: St Jude Medical Inc.
Published: 2017-08-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-08-28 / Terminated / root cause: software

FDA source

St Jude Medical Inc. began a recall of Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component... on 2017-08-28. FDA classified it as Class II and gives the reason as "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0033-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-28
Posted: 2018-06-12
Terminated: 2020-07-08
Recalling firm: Abbott Medical
Product: Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
Product code: OSR Pacemaker/Icd/Crt Non-Implanted Components
Reason for recall: New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Root cause tag: software
FDA root cause: Unknown/Undetermined by firm
Action: Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.
Quantity in commerce: 495,011 units (391,093 in US)
Distribution: Worldwide Distribution
Product codes and lots: Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0033-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0029-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0030-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0031-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0032-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0033-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0034-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0035-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0036-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0037-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19
Z-0038-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19

Product code OSR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)